Institutional Review Board (IRB)

The Essentia Health Institutional Review Board (IRB) reviews and evaluates proposed and ongoing human subjects research projects at Essentia Health to protect the rights and welfare of participants.

IRB Authority & Purpose

The IRB ensures research participants take part voluntarily and with safeguards from unnecessary or inappropriate risks in place. The IRB has also been designated to function as the privacy board under HIPAA requirements.

IRB Review of Research

The IRB tracks the progress of every Essentia research project, even before participant recruiting takes place. At least once a year, the IRB reevaluates each project and works with the principal investigator and other sources to make modifications, if needed, to safeguard participants.

IRB Membership

The Essentia Health IRB will include:

• At least five members with varying backgrounds to promote complete and adequate review of the research activities commonly conducted by Essentia Health
• At least one member whose primary concerns are in scientific areas
• At least one member whose primary concerns are in nonscientific areas
• At least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution

The Essentia IRB will:

• Ensure that the membership is not composed of entirely men or entirely women
• Disallow member participation in the initial or continuing review of any project the member has a conflicting interest in, except to provide information requested by the IRB

Federal Regulatory Guides for IRB

Federal regulations guide the Essentia Health IRB composition, operation, and responsibilities for human research participant protection processes. The Department of Health & Human Services (HHS) Office for Human Rights Protections (OHRP) oversees IRB operations and the Food and Drug Administration (FDA) enforces regulations for the use of experimental drugs and devices.

Federalwide Assurance

Through its Federalwide Assurance (FWA), Essentia Health pledges to comply with the Protection of Human Subjects (45 CFR part 46) regulations.

• FWA is a binding agreement between HHS and Essentia Health and is updated and renegotiated at regular intervals.
• Essentia Health FWA#: FWA00000635
• Verify Essentia Health's FWA

IRB Submission Deadlines

For consideration on the Essentia Health IRB agenda, complete IRB submissions in iRIS at least 14 days before the meeting date. IRB staff recommend submitting well before the 14-day deadline to ensure your submission is complete.

Essentia IRB Meeting Dates

The Essentia IRB meets monthly. The 2020 meeting dates and the corresponding submission due dates are listed below:

Deadline: The complete submission must be in the iRIS Administrative Pre-Review queue 14 days before (Submissions Due Date) the intended IRB Meeting Date for consideration on that agenda. FCOI surveys and/or management plans must be complete before IRB review. If FCOI surveys and/or management plans are not complete at least 7 days before the IRB meeting date, the submission will be deferred.

NOTE: If a submission does not qualify as complete on the Submissions Due Date it may not be considered at the corresponding IRB meeting. IRB staff recommend submitting prior to the Submissions Due Date and using pre-review checklists to ensure the submission is complete.

Revised: April 22, 2020

Contact Us

Learn more about the institutional review board (IRB). Call 218-576-0711. Email the IRB.